Successful Preparation Strategies For NDA/MAA Marketing Applications

Martha Plaza, M.B.A., Manager, Regulatory Affairs Project Management, Veristat; Kimberly Newton, M.A., Senior Director, Medical Writing, Veristat

No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. With each submission come special constraints, unique partnership dynamics, and a complex web of challenges due to timing of data analysis, medical writing, project management, and interaction with regulatory agencies. By utilizing key strategies, you can propel even the most complex submissions to successful regulatory conclusions. Read our Insight Brief to learn how to:

• Manage common operational complexities
• Overcome data analysis challenges
• Optimize the medical writing process